Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07125963

Patient-Specific vs. Conventional Positioning in Sagittal Split Ramus Osteotomy

This study aims to evaluate the clinical efficacy and positioning accuracy of a custom-made proximal segment positioning appliance designed for use in sagittal split ramus osteotomy (SSRO). The appliance is produced using STL-based digital planning and 3D printing technologies. In each patient, the appliance is applied to one side of the mandible while the contralateral side is positioned using the conventional manual method. This within-subject design enables direct comparison by eliminating inter-individual anatomical variability. The primary outcome is the accuracy of segment positioning, evaluated by 3D superimposition and deviation analysis of pre- and postoperative STL models. Secondary outcomes include surgical time, ease of use as rated by the surgeon, and postoperative temporomandibular joint symptoms. The study will enroll 30 adult patients undergoing SSRO or double-jaw surgery due to dentofacial deformities. The results are expected to provide high-level clinical evidence for the reliability of patient-specific appliances in orthognathic surgery.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Dentofacial Deformities Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Maxillofacial Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University, Medipol Mega University Hospital

Istanbul, Bağcılar, 34218, Turkey (Türkiye)

Location status: Recruiting

Location contact

Sümer Münevveroğlu, D.D.S., Ph.D.

CONTACT

[email protected]

00905386013666

Sümer Münevveroğlu, D.D.S., Ph.D.

PRINCIPAL_INVESTIGATOR

About this study

Sagittal split ramus osteotomy (SSRO) is a widely used orthognathic surgery technique to correct mandibular deformities. During SSRO, accurate positioning of the proximal segment is critical for ensuring temporomandibular joint (TMJ) health, symmetry, and long-term surgical stability. However, conventional positioning relies heavily on the surgeon's visual judgment and experience, which may lead to postoperative complications such as condylar displacement, facial asymmetry, and TMJ dysfunction.

This prospective, randomized clinical study introduces a patient-specific proximal segment positioning appliance developed through STL-based 3D design using Blender and printed with biocompatible surgical guide resin via a Formlabs SLA 3D printer. Each patient will undergo SSRO (with or without Le Fort I osteotomy), and the custom appliance will be used to guide the proximal segment on one mandibular side. The opposite side will be positioned conventionally, allowing intra-patient comparison.

Postoperative CBCT images will be obtained at 1 month and converted to STL format. These models will be aligned with preoperative plans using MeshLab software to evaluate linear and rotational deviations. Surgical time, ease of application, and TMJ symptoms will be documented. Statistical analysis will include paired t-tests or Wilcoxon signed-rank tests depending on data distribution.

This study will generate clinically meaningful data regarding the effectiveness and safety of patient-specific guides in mandibular segment positioning. The proposed method also holds commercialization potential and may reduce intraoperative variability and dependence on surgeon experience.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled to undergo bilateral sagittal split ramus osteotomy as part of orthognathic surgery
  • Age ≥ 18 years
  • Availability of preoperative and postoperative CT scans
  • Consent to participate in the study

Exclusion criteria

  • History of previous mandibular surgery
  • Craniofacial syndromes or congenital deformities
  • Incomplete radiological records

Treatment and study plan

Custom-made positioning appliance-assisted mandibular segment repositioning

Procedure

A patient-specific surgical guide designed using STL-based digital planning in Blender and produced via 3D printing with biocompatible surgical resin (Formlabs SLA printer). Used to guide and stabilize the proximal mandibular segment during sagittal split ramus osteotomy.

Conventional Manual Positioning

Procedure

The proximal mandibular segment is positioned manually by the surgeon based on visual and tactile feedback without the use of a positioning guide. This technique represents the standard method in sagittal split ramus osteotomy.

Primary outcomes

  1. Deviation of the proximal mandibular segment from the preoperative plan

    Time frame: 1 Month Postoperatively

    The deviation between the actual postoperative position of the proximal mandibular segment and the virtually planned position will be measured in millimeters using superimposed STL files in MeshLab software. The mean deviation value will be compared between the custom-made positioning appliance-assisted method and conventional manual positioning to assess positional accuracy.

Secondary outcomes

  1. Duration of Fixation After Split

    Time frame: Intraoperative

    The time required for fixation of the mandibular segments following sagittal split osteotomy will be recorded separately for each side. This period begins immediately after the osteotomy is completed and ends when rigid fixation is achieved. The recorded times will be compared between the custom-made positioning appliance-assisted method and the conventional manual method to evaluate potential differences in procedural efficiency.

Study contacts

Contact information is provided by the study sponsor or research team.

Sümer Münevveroğlu, D.D.S., Ph.D.

CONTACT

[email protected]

00905386013666

Sponsors and collaborators

Lead sponsor

Sümer Münevveroğlu

Other

Registry information

Official study title

Comparison of a Patient-Specific Proximal Segment Positioning Appliance and the Conventional Method in Sagittal Split Ramus Osteotomy

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 15, 2025
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.